FDA product code JGQ: Turbidimetric, Total Protein
JGQ is the FDA product code for turbidimetric, total protein. It is a Class II device, regulated under 21 CFR 862.1635 and reviewed by the Clinical Chemistry panel. FDA has cleared 13 510(k) submissions under JGQ, from 11 different applicants. The average 510(k) review took 74 days (median 50). FDA has posted 1 recall for JGQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Turbidimetric, Total Protein |
| Device class | Class II |
| Regulation | 21 CFR 862.1635 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JGQ clearance
Top JGQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 2 | 1998-10-01 |
| Em Diagnostic Systems, Inc. | 2 | 1990-04-16 |
| Hitachi Chemical Diagnostics, Inc. | 1 | 2013-06-07 |
| Roche Diagnostics Corp. | 1 | 2007-10-19 |
| Roche Diagnostics | 1 | 2007-09-14 |
6 more applicants have JGQ clearances. See the full list in Caduvo.
Most recent JGQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131051 | Hitachi Chemical Diagnostics, Inc. | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) | 2013-06-07 | 53 |
| K072638 | Roche Diagnostics Corp. | ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 | 2007-10-19 | 31 |
| K071239 | Roche Diagnostics | TOTAL PROTEIN URINE/CSF GEN.3 | 2007-09-14 | 134 |
| K981295 | Abbott Laboratories | UPRO | 1998-10-01 | 175 |
| K981682 | Abbott Laboratories | UPRO | 1998-09-21 | 131 |
Recalls for JGQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-12-19.
Frequently asked questions
What is FDA product code JGQ?
JGQ is the FDA product code for turbidimetric, total protein. It is a Class II device, regulated under 21 CFR 862.1635 and reviewed by the Clinical Chemistry panel.
What device class is JGQ?
Class II, regulation 21 CFR 862.1635. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JGQ?
Across 13 cleared submissions the average was 74 days from receipt to decision (median 50).
Which companies have the most JGQ clearances?
Abbott Laboratories (2); Em Diagnostic Systems, Inc. (2); Hitachi Chemical Diagnostics, Inc. (1); Roche Diagnostics Corp. (1); Roche Diagnostics (1).
Have JGQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-12-19.
Next steps
- Run an FDA pathway report with predicate devices for product code JGQ
- Run a recall and safety report across every JGQ manufacturer
- Watch product code JGQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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